The effectiveness of massage interventions on procedural pain in neonates: A systematic review and meta-analysis

Background: The painful procedures experienced by neonates during hospitalization have short-term or long-term effects on neonates. While the limitations of previous interventions make it imperative to explore effective interventions that are readily available. This systematic review and meta-analysis was conducted to evaluate the safety and effectiveness of massage for pain management in neonates. Methods: This systematic review was registered in PROSPER. PubMed, Embase, Cochrane Library, and the Clinical Trials Registry were searched to December 2021. Two reviewers independently carried out study selection, data extraction, bias risk assessment. Continuous data were analyzed by mean differences (MD). Dichotomous data were reported using relative risk. If at least two studies reported identical results by the same pain assessment tool, a meta-analysis was conducted using random effect model and inverse variance. Results: Total 11 included studies involving 755 neonates investigated the effects of massage on neonatal pain response compared to standard care. The meta-analysis showed that massage could effectively improve pain response in neonates compared to standard care no matter whether neonatal infant pain scale (NIPS) or premature infant pain profile (PIPP) was used as an assessment tool. Besides, massage was also effective for crying duration, blood oxygen saturation both during and after the procedure, but non-effective for the variation of respiratory rate after the procedure, and heart rate both during and after the procedure. Conclusions: Massage may have a positive effect on pain relief of neonate, and rigorous trials are needed in the future to determine the most effective massage method.

"Randomization was thus provided by this method so that those who drew envelopes with"1"from the jar were included in the control group, and those who drew envelopes with"2"were in the intervention group." The investigators describe a random component in the sequence generation process such as: Drawing of lots.
"The item in the neonatal information form indicating that the"newborn is in the control or intervention group"was not marked. This item was marked after the procedure to ensure that the researcher did not know which group the newborn was in." Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: Sequentially numbered, opaque, sealed envelopes.
The study did not address this outcome.
" The nurse then called the researcher back into the room. After the newborn was prepared for the procedure, the mother was asked to take her newborn in her arms, and the nurse duly conducted the heel lance. During the procedure, the newborn was evaluated by the investigator using the NIPS and NCBS." Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
No missing outcome data reported.
The study protocol not published, and study not registered.
The study appears to be free of other sources of bias.
"Then using free online software, the randomization list was generated" The investigators describe a random component in the sequence generation process such as: Referring to a random number table.
Insufficient information about the sequence generation process to permit judgement of 'Low risk' or 'High risk'.
The study did not address this outcome.
The study did not address this outcome.
No missing outcome data reported.
All of the study's prespecified outcomes have been reported.
The study appears to be free of other sources of bias.

Low risk of bias
Low risk of bias Unclear risk of bias "Cards written "acupressure", "massage" and "control" on them were placed in closed envelopes, and the mothers were asked to choose one of these envelopes." The investigators describe a random component in the sequence generation process such as: Shuffling cards or envelopes.
" Neonates were assigned in the acupressure, massage, and control groups with the closed envelope method." Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: Sequentially numbered, opaque, sealed envelopes.
Insufficient information to permit judgement of 'Low risk' or 'High risk'.
The study did not address this outcome.
Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
This study protocol is registered at ClinicalTrials.gov (NCT03906552).
All of the study's prespecified outcomes have been reported.
There may be a risk of bias, but insufficient information to assess whether an important risk of bias exist.

Unclear risk of bias
"Twenty five such envelopes had been prepared with the help of computer generated random numbers." The investigators describe a random component in the sequence generation process such as: Using a computer random number generator.
"Infants were randomised into two groups (massage first or massage second) by opening sequential sealed opaque envelopes." Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: Sequentially numbered, opaque, sealed envelopes.
"Blinding of the caretakers to the massage or nomassage intervention was ensured by pulling the curtains around the bed until the intervention was completed." Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
"All the parameters were recorded by the bedside nurse who was blinded to the intervention." Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
"Data of three infants could not be included because two were transferred to other hospitals before completion of the study and one was later discovered to have received morphine within 24 h prior to initiation of the study." Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
The study protocol not published, and study not registered.
The study appears to be free of other sources of bias.

Hyesang Im 2008
Unclear risk of bias The study protocol not published, and study not registered.
There may be a risk of bias, but insufficient information to assess whether an important risk of bias exist. investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: Sequentially numbered, opaque, sealed envelopes. No missing outcome data reported.

Low risk of bias Low risk of bias Unclear risk of bias
"The study protocol is registered (ID: IRCT2018010803826 5N2)." All of the study's prespecified outcomes have been reported.
There may be a risk of bias, but insufficient information to assess whether an important risk of bias exist. Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).

Low risk of bias Unclear risk of bias
The study protocol not published, and study not registered.
The study appears to be free of other sources of bias. The investigators describe a random component in the sequence generation process such as: Referring to a random number table.

judgement. intervention."
Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.

sampling."
Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.

Yongping Sun 2020
Low risk of bias Unclear risk of bias The method of concealment is not described or not described in sufficient detail to The study did not address this outcome.
The study did not address this outcome.
No missing outcome data reported.
The study protocol not published, and study not registered.
There may be a risk of bias, but insufficient information to assess whether an important risk of bias exist. Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
" 2 were excluded from the study due to Parental dissatisfaction with intervention, and 3 due to changes in treatment and intranasal tube use, and one neonate due to transfer to another hospital." Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).
The study protocol is registered (ID: IRCT2018050803958 7N1) Although cited as primary outcomes in protocol, no data were reported on variation of heart rate and oxygen saturation.
The study appears to be free of other sources of bias.
Note: Italics shows direct quotes from articles.